NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. To make meaningful and powerful research progress, foundational data upon which new advances will hinge must be reliable and reproducible. This is especially important in order to enable translation of preclinical findings into human applications intended to facilitate the development of new therapies. Toward this end, NIDA is committed to the support of translational studies involving animals, which are marked by transparency in reporting on the design, conduct and analysis of experiments. NIDA encourages the investigators proposing translational studies involving animals to address a core set of research parameters/reporting standards, as listed below.

NIDA believes that it is important for investigators and reviewers to consider the following points in study design and to address those that are appropriate. Keep in mind that many of the issues will be addressed in the Research Strategy section, others in the Vertebrate Animals section, and possibly others elsewhere in the grant application.

Experimental design:

Rationale for the selected models, including species, strain, housing, diet, sex, age and weight

Rationale for endpoints selected

Adequacy of the controls

Route, dosing and timing of treatment

Sample size estimates, including power calculation

Statistical methods to be used in analysis and interpretation of results, including justification for assuming normalized distribution if parametric statistics to be used

Minimizing bias:

Methods of blinding (allocation concealment and blinded assessment of outcome)

Inclusion and exclusion criteria

Strategies for randomization and/or stratification

Procedures for dealing with missing data due to attrition or exclusion

Reporting of all results (negative and positive)

Results:

Reporting of independent validation/replication, if available

Robustness and reproducibility of the observed results, including whether replicates involved different lots of animals, drugs, reagents, experimenters

Dose-response results

Verification that interventional drug or biologic reached and engaged the target

Applicants are encouraged to include the statements about sample size estimates, blinding, and randomization procedures, even if those procedures were not used.